NCT00678236

Brief Summary

The goal of this scientific study is to determine whether there are differences in early migration and prosthesis-near bone density when a standard knee prosthesis is fixed with Refobacin Bone Cement R or with Refobacin Plus Bone Cement. Migration will be evaluated with RSA and bone density around the prosthesis with DEXA. The study will be successful if the prosthesis is fixed and remains in place throughout the entire period of the study, that is, that there is no increasing migration as measured by RSA. The cement type that ensures the largest number of solidly fixed prostheses during the two-year evaluation period will be "the best".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

4 years

First QC Date

May 8, 2008

Last Update Submit

August 19, 2013

Conditions

Osteoarthritis

Keywords

RSAGonarthritisBone Cement

Outcome Measures

Primary Outcomes (1)

  • Tibial implant migration evaluated by RSA

    2013

Secondary Outcomes (1)

  • Comparison of Refobacin Bone Cement R vs. Refobacin Plus Bone Cement

    2013

Study Arms (2)

1

ACTIVE COMPARATOR

Refobacin Bone Cement R

Other: Refobacin Bone Cement R

2

ACTIVE COMPARATOR

Refobacin Plus Bone Cement

Other: Refobacin Plus Bone Cement

Interventions

Refobacin Bone Cement ROTHER

Insertion of a knee prosthesis fixed by Refobacin Bone Cement R

Also known as: Biomet Europe: Refobacin Bone Cement R
1
Refobacin Plus Bone CementOTHER

Insertion of a knee prosthesis fixed by Refobacin Plus Bone Cement

Also known as: Biomet Europe: Refobacin Plus Bone Cement
2

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • primary or secondary knee osteoarthritis
  • sufficient bone quality for total knee arthroplasty
  • age above 70 years
  • no upper age limit if the patient is capable
  • informed and written consent
  • patient can only enter the project with one knee

You may not qualify if:

  • neuromuscular or vascular disease in the affected leg
  • preoperatively not found suitable for a knee arthroplasty
  • patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
  • fracture sequelae or previous PTO or previous extensive knee surgery
  • patients with need of a stem-elongation
  • patients who cannot refrain from taking NSAID post-operatively
  • continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bon emineral density by a factor of 5
  • patients with metabolic bone disease
  • patients with rheumatoid arthritis
  • postmenopausal women in estrogenic hormone substitution
  • patients with a continuous need of systemic cortisone treatment
  • non-Danish citizenship
  • patients who do not comprehend the Danish language (read and speak)
  • senile dementia
  • alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

gentamicin-polymethylmethacrylate beadBone Cements

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Resins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Kjeld Soballe, MD, Prof.

    Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Århus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 15, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

DK(1)